Quick SARS-CoV-2 rRT-PCR Kit
R3011 / R3011-1K / R3011-10K
- Approved for emergency use authorization (EUA) by the U.S. Food and Drug Administration and CE-IVD certified.
- High Sensitivity: Ranked among the top three most sensitive EUA tests by the FDA, with a Limit of Detection as low as 250 GEC/ml (15 GEC/reaction).
- Specific: Detection of SARS-CoV-2 and Emerging Strains (including Omicron)
- Rapid & Easy Setup: Ready-to-use Master Mix, just add sample.
- Compatible with Automated and High-Throughput workflows.
The Quick SARS-CoV-2 rRT-PCR Kit is a real-time reverse transcription PCR (rRT-PCR) test for the qualitative detection of RNA from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is responsible for the coronavirus disease (COVID-19).
The Quick SARS-CoV-2 rRT-PCR Kit detects N1, N2, and N3 regions of the viral nucleocapsid (N) gene and a host-specific target region (human RNase P gene) to assess sample quality. The kit also includes CV Positive Control that enable assay performance monitoring, and a No-Template Control to confirm the absence of contamination in the reagents.
The Quick SARS-CoV-2 rRT-PCR Kit can be used on purified RNA samples isolated from upper respiratory and lower respiratory systems.
The Quick SARS-CoV-2 rRT-PCR Kit has High Sensitivity, with a Limit of Detection as low as 15 viral genome equivalent copies per reaction, a fast turnaround time of less than 1.5 hours, and a simple workflow in which RNA is simply added to the Quick SARS-CoV-2 rRT-PCR Kit reagents and directly analyzed.
Due to its simplicity, set-up up can be performed in an automation and it is compatible with high-throughput platforms. The kit is compatible with multiple Real-Time PCR instruments and technical support is available for all steps of the setup process and data interpretation.
In the United States:
Qualitative assay for use on the Bio-Rad CFX96 Real-Time PCR Detection System. For use under the FDA Emergency Use Authorization (EUA) only. For in vitro diagnostic use.
|Compatibility||Compatible with automated and high-throughput workflows.|
|Equipment Required||Real-Time PCR Instruments capable of detecting HEX™ and Quasar® 670/Cy5 fluorophores.|
|Input Quality||Purified RNA free of enzymatic inhibitors.|
|Processing Time||≤ 1.5 hours from set up to results.|
|Reagents||Complete and ready to use master mixes.|
|Registration Status||FDA-Emergency Use Authorization
|Sample Input Material||Purified RNA samples isolated from upper respiratory and lower respiratory systems.|
Q1: Is the Quick SARS-CoV-2 rRT-PCR Kit a diagnostic test?
This test has been authorized by the U.S. FDA under an EUA and CE-IVD certified for use by authorized laboratories. In the U.S. this test is only authorized for the duration of that circumstances exist justifying the authorization of emergency use of in vitro diagnostic test for detection and/or diagnosis of COVID-19 under Section 564(b)(I) of the Act, 21 U.S.C. § 360bbb-3(b)(I), unless the authorization is terminated or revoked sooner.
Q2: Can I use Quick SARS-CoV-2 rRT-PCR Kit for the detection of pathogens other than SARS-CoV-2?
This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other virus or pathogen.
Q3: I cannot interpret the results.
Please refer to the Interpretation of Results, the Appendix, and the Troubleshooting Guide sections in our Quick SARS-CoV-2 rRT-PCR Kit protocol. If you still have problems with the result interpretation please contact our Technical Support team at (949) 679-1190 ext. 3 or e-mail us at email@example.com.
Q4: Amplification curves look strange.
Sometimes aberrant qPCR signal are observed. Please refer to the Interpretation of Results, the Appendix, and the Troubleshooting Guide sections in our Quick SARS-CoV-2 rRT-PCR Kit protocol. If you still have problems with the result interpretation please contact our Technical Support team at (949) 679-1190 ext. 3 or e-mail us at firstname.lastname@example.org.
Q5: The No-Template Control show an amplification signal. What should I do?
This may indicate incorrect plate set-up or a contamination in the No-Template Control or in the CV Mix 1 and/or 2. We recommend to use a new aliquot of reagents.
Q6: The CV Positive Control doesn’t amplify. What should I do?
This may indicate incorrect plate set-up or the compromise of Quick SARS-CoV-2 reagents. We recommend to use a new aliquot of reagents.
Q7: RNase P human target (Quasar 670®) amplified after cycle 40 or didn’t amplify at all. How do I interpret the results?
If the host target didn’t amplify or shows CT values above 40, your RNA extraction and/or RT-PCR reaction may have been incorrectly performed. We suggest repeating RNA extraction and the RT-PCR reaction.
Q8: Signal for SARS-CoV-2 viral targets (HEX™ channel) was detected late, between cycle 35 and 45. Is this a valid signal? How do I interpret the results?
Late signal for SARS-CoV-2 viral targets may be indicative of a low viral load in your sample. We suggest repeating the RT-PCR to confirm results.
Q9: Why SARS-CoV-2 and human Rnase P targets are detected in two separate RT-PCR reactions?
Viral and human targets are amplified in two separate reactions in order to prevent potential competition between PCR. Detecting viral and human targets in two separate reaction minimizes false negative results even in samples with extremely low viral titer.
Q10: How the Quick SARS-CoV-2 rRT-PCR Kit performs compared to other FDA EUA and CE-IVD molecular tests?
With a limit of detection(LoD) as low as 15 GEC/reaction the Quick SARS-CoV-2 rRT-PCR Kit outperforms most of the SARS-CoV-2 molecular tests present on the market.
In addition, the detection of a host target (human Rnase P) allow the identification of insufficient samples, which other tests may classify as negative; this further reduce the chances of the false negative results.
The end-to-end EUA authorized workflow consists of sample collection, sample preparation, and real-time RT-PCR analysis.
Authorized laboratories using the Quick SARS-CoV-2 rRT-PCR Kit must run the assay as outlined in the Instructions for Use. Deviations from the FDA authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to perform the Quick SARS-CoV-2 rRT-PCR Kit are not permitted.